Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)
Reason given: Business objectives have changed
Key facts
- Where
- Cleveland, Houston, and Nashville, United StatesSee the 3 sites
- Phase
- Phase 1
Where in United States
- Local Institution - 019-104Cleveland, United StatesNo longer taking part
- Local Institution - 019-102Houston, United StatesNo longer taking part
- Local Institution - 019-101Nashville, United StatesNo longer taking part
Trial details
- Who runs it
- Mirati Therapeutics Inc.
- Trial code
- NCT05840510
- Record updated
- 25 April 2025
- Original description
This study will evaluate the safety, MTD and/or RP2D, PK, and clinical activity of the combination of adagrasib with nab-sirolimus in patients with advanced solid tumors/NSCLC with a KRAS G12C mutation.Read full original descriptionShow less
A Phase 1/2 Trial of Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation
This study will evaluate the safety, MTD and/or RP2D, PK, and clinical activity of the combination of adagrasib with nab-sirolimus in patients with advanced solid tumors/NSCLC with a KRAS G12C mutation.
Inclusion: Histologically confirmed diagnosis of solid tumor malignancy (Phase 1) or NSCLC (Phase 2) with KRAS G12C mutation; Unresectable or metastatic disease; No available treatment with curative intent; Adequate organ function; Measurable disease per RECIST 1.1.
Exclusion: History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow; History of interstitial lung disease or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease or pneumonitis; Cardiac abnormalities.